510(k) Report

FDA applicant

Meditera Tibbi Malzeme San VE Tic AS

Izmir, TR3 decisions2020–20211 recall

FDA records 3 decisions for Meditera Tibbi Malzeme San VE Tic AS (Izmir, TR) from 2020 to 2021: 3 510(k) clearances. Most are in product codes CBP (Valve, Non-Rebreathing) and CAH (Filter, Bacterial, Breathing-Circuit). Its devices cite 3 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Meditera Tibbi Malzeme San VE Tic AS’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2020: 22021: 1
2020high 2 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2020high 1 (2023) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — Meditera Tibbi Malzeme San VE Tic AS by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Meditera Tibbi Malzeme San VE Tic AS’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • CBPValve, Non-Rebreathing1decision
  • CAHFilter, Bacterial, Breathing-Circuit1decision
  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K192713Altera Filter and HME/FilterMeditera Tibbi Malzeme San VE Tic AS · 20201cites it

What has FDA decided for it lately?

  • K210992Altech® Exhalation Valve (Single Limb and Dual Limb)Meditera Tibbi Malzeme San VE Tic AS · 2021
  • K192713Altera Filter and HME/FilterMeditera Tibbi Malzeme San VE Tic AS · 20201 recall
  • K192563Altera gas Sampling LinesMeditera Tibbi Malzeme San VE Tic AS · 2020

All 3 as Meditera Tibbi Malzeme San VE Tic AS →

What has been recalled?

1 recall linked to its devices; the latest:

  • K192713abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm…Jan 5, 2023Class III